Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Information provided by (Responsible Party):
Sharon Walsh, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00617201
First received: February 5, 2008
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent individuals, who are healthy and are seeking treatment for their substance abuse, will be randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve maintenance on the assigned active dose safely. Contingency management procedures will be used to reinforce attendance and compliance with study procedures. Primary outcome measures will include urinalysis data assessing cocaine use.


Condition Intervention Phase
Substance Abuse
Drug: atomoxetine
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • % Urine Samples Negative for Cocaine [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Total % urine samples negative for benzoylecgonine over the 12-week trial


Secondary Outcome Measures:
  • Retention [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
    Trial retention- those who complete the 12 week dosing period


Enrollment: 50
Study Start Date: July 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Atomoxetine
Drug: atomoxetine
Once daily oral dosing
Other Name: Straterra
Placebo Comparator: 2
Matched Placebo
Drug: placebo
Once daily oral dosing - matched placebo

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Seeking treatment for cocaine dependence
  • Must have used cocaine in the past 30 days

Exclusion Criteria:

  • Physical dependence on any drug requiring medical management
  • Any major medical or psychiatric disorder that would be contraindicated for participation
  • Cardiovascular disease
  • Seizures or significant head injuries
  • Currently taking atomoxetine
  • Pregnant or breast-feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617201

Locations
United States, Kentucky
Straus Research Building
Lexington, Kentucky, United States, 40502
Sponsors and Collaborators
University of Kentucky
Eli Lilly and Company
Investigators
Principal Investigator: Sharon L Walsh, Ph.D. University of Kentucky
  More Information

No publications provided

Responsible Party: Sharon Walsh, Director Center on Drug and Alcohol Research, University of Kentucky
ClinicalTrials.gov Identifier: NCT00617201     History of Changes
Other Study ID Numbers: #07-0041, R01DA022191
Study First Received: February 5, 2008
Results First Received: November 13, 2012
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
cocaine
dependence
stimulants

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Atomoxetine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on August 28, 2014